High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Optional)

High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Optional), Limited Submission Opportunity

The development and implementation of clinical interventions is a complex, iterative and time-consuming process that takes years before discoveries in biomedical research result in health benefits for patients and communities. The National Center for Advancing Translational Sciences (NCATS) has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist in the translational process and develop innovative solutions that will ultimately benefit research across a range of diseases and conditions. This disease-agnostic approach to enhancing the efficiency and effectiveness of all translational research is known as translational science, which focuses on building the evidence base for effective scientific and operational approaches in translational research. NCATS conducts and supports research in the science of translation to discover the scientific, mechanistic and operational principles of the intervention development and dissemination processes, thereby providing the scientific foundation for improvements in translational efficiency that will accelerate the realization of interventions that improve human health.

The purpose of the High Impact Specialized Innovation Programs (SIPs) is to support unique activities, resources, capabilities and/or expertise at awarded Clinical and Translational Science Award (CTSA) UM1 hubs, such as The Ohio State University’s Center for Clinical and Translational Science (CCTS), to help advance one or more of the NCATS CTSA Program goals. The SIPs initiative is envisioned as part of the current innovation ecosystem to support the generation of a research resource and/or foster discovery-based or hypothesis-generating science that can have a significant impact in Clinical and Translational Science (CTS).

This FOA seeks to support novel approaches in areas that address specific knowledge gaps, scientific opportunities, new technologies/platforms, data generation and/or analysis or novel research methods that will advance CTS and Clinical and Translational Research (CTR) at CTSA UM1 hubs. Resources, activities and expertise supported through the RC2 mechanism are expected to be available to enhance the development and demonstration activities or projects within a CTSA hub. These include utilization of resources, expertise, tools and platforms for pilot projects, research projects and other CTS activities within hubs.

Examples of SIPs areas in clinical and translational science include, but are not limited to, digital health, decentralized clinical trials, pragmatic trials, artificial intelligence/machine learning algorithms, point-of-care clinical decision support systems, data science and statistical methods, real-world data and real-world evidence, innovative clinical trial designs, genetics and genomics. In addition, novel strategies and/or approaches for dissemination and implementation, rural health and health disparities, clinical informatics, biostatistics, community outreach and engagement, regulatory science, telehealth and other areas of need for specialized programs.

Scope and Specific Requirements:

Through the RC2 mechanism, SIPs should address one or more of the following objectives:

• Groundbreaking, innovative, high impact and cross-cutting research, resources and/or activities that address one or more of the CTSA Program Goals and have the highest potential to improve and accelerate biomedical research at UM1 hubs
• Programs in CTS that could fundamentally enhance the research enterprise and that require the participation, interaction, coordination and integration of activities within a CTSA UM1 hub
• Creation of unique resources and/or development of transformative technologies and/or platforms that can benefit a wide range of projects and/or activities related to CTS at CTSA UM1 hubs
• High-impact discovery-based projects or hypothesis-generating science

Collaborations with other cores/teams/programs of The Ohio State University CCTS or its partners and collaborators (Nationwide Children’s Hospital, Bon Secours Mercy Health (BSMH) and Ohio Primary Care Innovation Network (OPCIN), are encouraged. Also, collaborations with other CTSA hubs and with non-CTSA organizations are encouraged.

Highlighted Review Criteria:

• If successful, to what degree will the results of this program help advance CTS and expedite the development of new science, resources, approaches, therapeutics, devices, software applications and/or other tools/platforms at UM1 hubs?
• In what way does this application fill a gap or address a problem/roadblock or area of need that will help advance clinical and translational science at the CTSA hub?
• If the application proposes the generation of a research resource or tool, to what degree will successful completion of this project generate a research resource or tool that will be highly useful and/or transformative for the broader clinical and translational science community? If so, how will it be financially sustained beyond the funding period?
• How adequate is the justification that the project or generated results and resources could be generalizable to the broader CTSA consortium community?

Important Notes:

• Please review the full FOA prior to applying to the internal competition
• It is the responsibility of the PI to ensure that both the application and all project participants are eligible for this opportunity and are prepared to submit a full application to NCATS if selected
• The selected proposal/team will work with the CCTS grant administrators and senior leadership to prepare and submit the application to NCATS. If funded, this award will be held within the CTSI ORG, including all facilities and administrative funds flow

Required Application Information

1. Research Summary: PDF Format Only, five pages. The research summary must include:

• Specific aims (one-page maximum)
• A brief overview of the proposed work, including how it will fulfill expectations of the RC2 (two-page maximum)
• Statement about your project’s novel approach and how it will address specific knowledge gaps, scientific opportunities, new technologies/platforms, data generation and/or analysis or novel research methods that will advance clinical and translational science and research, specifically to address the “highlighted review criteria” (one-page maximum)
• A brief description of how this proposal integrates with/enhances the CTSA UM1 award (half-page maximum); if you need a copy of the specific aims of the proposal contact Tiffany Bernard
• Description of the research team (half-page maximum)

1. PI NIH Biosketch: PDF Format Only. Please combine into a SINGLE document if there are multiple PIs.

Review Process:

Applications will be reviewed by The Ohio State University CCTS leadership team, who will evaluate the likelihood that the proposed project will be funded by the sponsor. Applicants will be notified of the final decisions with enough time to prepare a full proposal to the sponsor.

The internal deadline for this competition is July 15, 2024. Upcoming deadlines are September 13, 2024, and January 13, 2024. Anyone submitting for consideration for this limited competition should only do so if they can commit to meeting one of these deadlines. Applicants chosen to represent the Ohio State/Nationwide Children’s CTSA with an RC2 application are expected to provide the penultimate version of their research proposal no later than August 30, 2024, for the September deadline or January 2, 2025, for the January deadline for review and approval by CTSA leadership. Failure to submit by the January 2025 deadline will result in the loss of opportunity to submit an RC2 on behalf of Ohio State. The ability to provide a resubmission will depend on the score, summary statement and the other high quality proposal ideas at Ohio State that were not selected. Generally, teams will only be given the opportunity of one resubmission.   

Contact:

Please contact Tiffany.Bernard@osumc.edu with any questions regarding this internal competition.

Access the submission application. 

Learn more about the RC2 mechanism. 

Watch the NCATS informational video about the RC2.